The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19 (ENDCOV-I)

  • STATUS
    Recruiting
  • End date
    Apr 5, 2024
  • participants needed
    170
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 5 May 2022
nintedanib
fibrosis
bronchiectasis
assisted ventilation
forced vital capacity
interstitial lung disease

Summary

This is a collaborative study between Icahn School of Medicine at Mount Sinai, Boehringer Ingelheim Pharmaceuticals and up to 9 other clinical centers across the US to determine the effect of Nintedanib on slowing the rate of lung disease in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 30 days out from their diagnosis.

Description

The purpose of this study is to determine the efficacy of the study drug, Nintedanib, on slowing the rate of lung disease in patients who are noted to have infiltrates, or ongoing lung injury, on chest x-ray/CT 30 days or longer from their initial symptoms. In addition, the study will also investigate patient reported outcomes using questionnaires, and the safety and tolerability of the study drug. Blood specimens will be collected to assess biomarkers and monitor drug safety.

The trial will be randomized 1:1 between Nintedanib and placebo.

Nintedanib has been approved by the FDA for the treatment of chronic fibrosing ILD with a progressive phenotype, but has not been studies in patients with post COVID 19 lung disease.

Subjects participating in this study will:

  • Attend in person visits to the study doctor's office on the date of enrollment, 15 days after enrollment, 45 days after enrollment, 90 days after enrollment, 135 days after enrollment, and 180 days after enrollment. If the participant is being enrolled in the study while hospitalized at Mount Sinai, the study doctor will travel to the hospital room.
  • Undergo a HRCT (High-resolution computed tomography) scan of the chest within 14 days of enrollment, and then again at 180 days after enrollment.
  • Have Pulmonary Function Tests within 14 days of enrollment, and then again 45, 90, 135 and 180 days after enrollment.
  • Have a six-minute walk test at baseline, day 90 and day 180 after enrollment.
  • Have blood drawn routinely while participating in this study (15 days after starting medication, then again on day 45, 90, 135 and 180).
  • Participants will not pay for physician visits, blood draws, breathing tests, CT scans or the medication for this study. Participants will receive a stipend to cover the transportation costs for your visits.

The main risks to participants are:

  1. Common side effects include: nausea, vomiting, diarrhea, stomach discomfort
  2. Loss of appetite and weight loss
  3. Liver function abnormalities (blood work will be monitored periodic intervals at scheduled blood draws as listed above)
  4. Slightly higher risk of bleeding
  5. Slightly higher risk of blood clots that can form in the blood vessels that supply oxygen to vital organs such as the brain and heart

Benefits from participation in this research include the possibility that Nintedanib may slow down/prevent progression of lung fibrosis. If the lungs can heal without fibrosis, this may result in fewer symptoms of shortness of breath, cough and need for added oxygen.

Instead of participating in this research, subjects may choose to monitor their lung condition with their doctor or participate in another research study.

Details
Condition Pulmonary Fibrosis, Interstitial Lung Disease, Respiratory Disease
Treatment Placebo, Nintedanib
Clinical Study IdentifierNCT04619680
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to provide written informed consent
Subjects Age ≥ 18
Initial SARS-CoV-2 infection confirmed by PCR test or positive serologies
Have findings consistent with interstitial lung disease found on CT scan (these may include ground glass opacities, reticulations, traction bronchiectasis, septal thickening, and early honeycombing)
Required one of the following after diagnosis with SARS-CoV-2: supplemental oxygen by nasal cannula, high flow oxygen, non invasive ventilation such as CPAP or BIPAP, or mechanical ventilation
Are at least 30 days from onset of initial SARS-CoV-2 symptoms
Forced Vital Capacity less than or equal to 90% predicted based on ATS/ERS criteria or DLCO less than or equal to 70%
Women of childbearing potential who agree to use of highly effective contraception during treatment and for three months following the last dose of nintedanib

Exclusion Criteria

Candidates will be excluded from study entry if any of the following exclusion criteria
exist at the time of the Screening Visit (prior to randomization)
Co-administration of other investigational agents against COVID-19
Active SARS-CoV-2 infection based on clinical judgment
Currently Pregnant or Breast Feeding
Current Use of Prednisone or equivalent > 10 mg/daily
Use of full dose anticoagulation therapy or high dose anti platelet drug therapy at
History of myocardial infarction within past 90 days
screening (at the discretion of the investigator, anticoagulation therapy may be added
if clinically indicated)
Life threatening bleed
Hemodynamic instability or shock
Superimposed pulmonary bacterial infection
Pre-existing interstitial lung disease
Active Hep A/B/C hepatitis as measured with PCR for viral load and/or serologies
Subjects with a Creatinine clearance <30 ml/min or currently on hemodialysis
Pre-existing liver disease: Including Abnormal Laboratory Liver Function: Childs Pugh
B/C, AST/ALT > 3 times the upper limit of normal (ULN). If Child Pugh A, can
participate on Nintedanib 100 mg by mouth twice daily
Inability to tolerate orally administered medication (medication must be taken with
meals)
Patients who are in the intensive care unit (ICU) or in the step-down unit on invasive
or non-invasive mechanical ventilation, ECMO, or high flow nasal cannula oxygen, will
not be included
Any condition that in the opinion of the Investigator, constitute a risk or a
contraindication for the participation of the patient into the study or that could
interfere with the study objectives, conduct or evaluation
Patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the
excipients
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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